128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave, Removable 2 Gang (Blue, Yellow) 1o2 Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
FDA Recall Z-2639-2018 · Posted None
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2017-07-31
Date Terminated2019-03-12
Product Quantity160,016 units total
Reason for Recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Firm Action
The firm, ICUmedical, notified their customers of the recall on about 07/31/2017 via"URGENT: Medical Device Recall Notification letter". Instructions included to inspect inventory on hand for affected devices, remove and return any affected devices, and complete and return the Recall Response Form to ICU Medical RecallCoordinator; email:[email protected]; including labeling "Incorrect labeling" in subject or FAX: (801) 264-1755. Instructions also included to notify customers of the recall if devices were further distributed.
Questions can be directed to ICU Customer Service Monday through Friday, 7 AM CST - 4:30 PM CT at 877-946-7747, option 9 or e-mail at [email protected]
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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